Clinical Trials Register

Summary
EudraCT Number:	2020-000474-16
Sponsor's Protocol Code Number:	NN1436-4480
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-08-03
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2020-000474-16

A.3

Full title of the trial

ONWARDS 4 - A 26-week trial comparing the effect and safety of once weekly insulin icodec and once daily insulin glargine 100 units/mL, both in combination with bolus insulin with or without non-insulin anti-diabetic drugs, in subjects with type 2 diabetes on a basal-bolus regimen.

ONWARDS 4. - Studio clinico di 26 settimane per confrontare gli effetti e la sicurezza dell’insulina settimanale icodec e dell’insulina giornaliera glargine 100 unità/mL, entrambe in combinazione con insulina prandiale, con o senza un trattamento antidiabetico non insulinico, in soggetti con diabete di tipo 2 trattati con insulina prandiale e insulina basale.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

ONWARDS 4 - A research study to compare two types of insulin, a new weekly insulin, insulin icodec and an available daily insulin, insulin glargine, both in combination with mealtime insulin, in people with type 2 diabetes who use daily insulin and mealtime insulin

ONWARDS 4 - Studio clinico di confronto tra due tipi di insuline, una nuova a somministrazione settimanale (insulina icodec) ed una nota a somministrazione giornaliera (insulina glargine), entrambe in combinazione con insulina ai pasti, in persone con diabete di tipo 2 che assumono già insulina giornaliera e insulina ai pasti

A.3.2

Name or abbreviated title of the trial where available

ONWARDS 4

A.4.1

Sponsor's protocol code number

NN1436-4480

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1247-5269

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	NOVO NORDISK. S.P.A.
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Novo Nordisk A/S
B.4.2	Country	Denmark
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Novo Nordisk A/S
B.5.2	Functional name of contact point	Clinical Disclosure (1452)
B.5.3	Address:
B.5.3.1	Street Address	Novo Allé
B.5.3.2	Town/ city	Bagsværd
B.5.3.3	Post code	2880
B.5.3.4	Country	Denmark
B.5.4	Telephone number	004544448888
B.5.5	Fax number	004544490555
B.5.6	E-mail	clinicaltrials@novonordisk.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	insulin icodec 700 U/mL PDS290
D.3.2	Product code	[.]
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	INSULINA
D.3.9.2	Current sponsor code	Insulina 287
D.3.9.3	Other descriptive name	Insulin 287
D.3.9.4	EV Substance Code	SUB50453
D.3.10	Strength
D.3.10.1	Concentration unit	nmol/ml nanomole(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	4200
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	LANTUS - 100 IU/ML SOLUZIONE INIETTABILE IN CARTUCCIA - USO SOTTOCUTANEO - CARTUCCIA VETRO PER OPTICLICK 3 ML" 5 CARTUCCE
D.2.1.1.2	Name of the Marketing Authorisation holder	SANOFI-AVENTIS DEUTSCHLAND GMBH
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Lantus
D.3.2	Product code	[N/A]
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Insulina glargine
D.3.9.1	CAS number	160337-95-1
D.3.9.2	Current sponsor code	N/A
D.3.9.3	Other descriptive name	Insulin glargine
D.3.9.4	EV Substance Code	SUB08196MIG
D.3.10	Strength
D.3.10.1	Concentration unit	U/ml unit(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	NOVORAPID - FLEXPEN 100 U/ML SOLUZIONE INIETTABILE 5 CARTUCCE IN PENNE PRERIEMPITE 3 ML USO SOTTOCUTANEO
D.2.1.1.2	Name of the Marketing Authorisation holder	NOVO NORDISK A/S
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Novorapid®
D.3.2	Product code	[N/A]
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	INSULINA ASPART
D.3.9.1	CAS number	116094-23-6
D.3.9.2	Current sponsor code	N/A
D.3.9.3	Other descriptive name	Aspart Isulin
D.3.9.4	EV Substance Code	SUB08195MIG
D.3.10	Strength
D.3.10.1	Concentration unit	U/ml unit(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Diabetes Mellitus, Type 2

Diabete Mellito di Tipo 2

E.1.1.1

Medical condition in easily understood language

Type 2 diabetes

Diabete Tipo 2

E.1.1.2

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10045242
E.1.2	Term	Type II diabetes mellitus
E.1.2	System Organ Class	100000004861

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To demonstrate the effect on glycaemic control of once weekly insulin icodec in combination with insulin aspart, with or without non-insulin anti-diabetic drugs, in subjects with type 2 diabetes (T2D) on a basalbolus regimen. This includes comparing the difference in change from baseline in glycosylated haemoglobin (HbA1c) between insulin icodec
and insulin glargine after 26 weeks of treatment to a non-inferiority limit of 0.3%.

Dimostrare l’effetto sul controllo glicemico dell’insulina icodec una volta alla settimana, in combinazione con l’insulina aspart, con o senza farmaci antidiabetici non insulinici, in soggetti con DT2 in regime di trattamento con insulina basale e rapida. Ciò include confrontare la differenza nella variazione dal basale della HbA1c tra insulina icodec e insulina glargine dopo 26 settimane di trattamento, per un limite di non-inferiorità dello 0,3%.

E.2.2

Secondary objectives of the trial

To compare safety with once weekly insulin icodec versus once daily insulin glargine, both in combination with insulin aspart, with or without non-insulin anti-diabetic drugs, in subjects with T2D on a basal-bolus regimen.

Confrontare il parametro della sicurezza dell’insulina icodec assunta una volta alla settimana rispetto all’insulina glargine assunta una volta al giorno, in combinazione con insulina aspart, con o senza farmaci antidiabetici non insulinici, in soggetti con DT2 in regime di trattamento con insulina basale e rapida.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Male or female aged above or equal to 18 years at the time of signing informed consent.
- Diagnosed with T2D 180 days or more prior to the day of screening.
- HbA1c from 7.0-10.0% (53.0-85.8 mmol/mol) both inclusive at screening confirmed by central laboratory analysis.
- Treated with once daily basal insulin (neutral protamine hagedorn insulin, insulin degludec, insulin detemir, insulin glargine 100 units/mL, or insulin glargine 300 units/mL) and 2-4 daily injections of bolus insulin analog (insulin aspart, faster acting insulin aspart, insulin lispro, insulin glulisine) 90 days or more prior to the day of screening with or without any of the following anti-diabetic drugs/regimens with stable doses 90 days or more prior to screening:
-Metformin
-Sulfonylureas
-Meglitinides (glinides)
-Dipeptidyl peptidase-4 (DPP-4) inhibitors
-Sodium-glucose Cotransporter-2 (SGLT2) inhibitors
-Thiazolidinediones
-Alpha-glucosidase inhibitors
-Oral combination products (for the allowed individual oral antidiabetic drugs)
-Oral or injectable glucagon-like peptide-1 (GLP-1) receptor agonists
- Body mass index (BMI) equal to or below 40.0 kg/m^2.

- Soggetti di sesso maschile o femminile con età pari o superiore ai 18 anni al momento della firma del modulo di consenso informato.
- Diagnosi di DT2 =180 giorni prima del giorno dello screening.
- HbA1c nell’intervallo 7,0-10,0% (53,0–85,8 mmol/mol), estremi compresi, allo screening confermata da analisi del laboratorio centrale.
- Trattamento con insulina basale giornaliera (protamina neutra hangedorn, degludec, detemir, glargine 100 unità/mL, glargine 300 unità/mL) e trattamento da 2 a 4 volte al giorno con insulina prandiale (aspart, aspart ad azione più rapida – faster aspart –, lispro, lispro ad azione più rapida – ultra rapid lispro –, glulisina) = 90 giorni dalla visita di screening, con o senza la seguente terapia antidiabetica con dose stabile = 90 giorni dalla visita di screening:
• Metformina
• Sulfaniluree
• Meglitinidi (glinidi)
• Inibitori di DPP-4
• Inibitori di SGLT-2
• Tiazolidinedioni
• Inibitori dell’alfa-glucosidasi
• Prodotti di combinazione per via orale (per i singoli farmaci antidiabetici orali consentiti)
• Agonisti recettoriali del GLP-1 orali o iniettabili
- Indice di massa corporea (IMC) =40,0 kg/m2.

E.4

Principal exclusion criteria

- Any episodes (as declared by the subject or in the medical records) of diabetic ketoacidosis within 90 days prior to the day of screening.
- Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening.
- Chronic heart failure classified as being in New York Heart Association Class IV at screening.
- Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids).
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

- Qualsiasi episodio di chetoacidosi diabetica negli ultimi 90 giorni precedenti il giorno dello screening.
- Infarto del miocardio, ictus, ricovero per angina pectoris instabile o attacco ischemico transitorio nei 180 giorni precedenti il giorno dello screening.
- Insufficienza cardiaca cronica di Classe IV secondo la New York Heart Association allo screening.
- Inizio anticipato o variazione (per oltre 14 giorni consecutivi) nell’assunzione di farmaci concomitanti dei quali è nota l’influenza sul peso o sul metabolismo glicemico (ad es. trattamento con orlistat, ormoni tiroidei o corticosteroidi).
- Retinopatia o maculopatia diabetica non controllata o potenzialmente instabile, verificata mediante esame del fondo oculare eseguito negli ultimi 90 giorni precedenti lo screening o nell’intervallo di tempo compreso tra lo screening e la randomizzazione. La dilatazione farmacologica della pupilla è un requisito a meno che non venga usata una fotocamera digitale specifica per un esame del fondo oculare senza dilatazione della pupilla.

E.5 End points

E.5.1

Primary end point(s)

Change in HbA1c

Variazione nella HbA1c (emoglobina glicata)

E.5.1.1

Timepoint(s) of evaluation of this end point

From baseline week 0 (V2) to week 26 (V28)

Dal valore basale (settimana 0, V2) alla settimana 26 (V28)

E.5.2

Secondary end point(s)

1. Change in fasting plasma glucose (FPG)
2. Time in target-range 3.9–10.0 mmol/L (70-180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6
3. Number of severe hypoglycaemic episodes (level 3)
4. Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by blood glucose (BG) meter)
5. Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3)
6. Time spent below 3.0 mmol/L (54 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6
7. Time spent above 10 mmol/L (180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6
8. Mean weekly insulin dose
9. Change in body weight

1. variazione della glicemia a digiuno (FPG)
2. Tempo nell'intervallo target 3,9-10,0 mmol / L (70-180 mg/dL) misurato utilizzando il sistema di monitoraggio continuo del glucosio (CGM), Dexcom G6
3. Numero di episodi ipoglicemici gravi (livello 3)
4. Numero di episodi ipoglicemici clinicamente significativi (livello 2) (inferiore a 3,0 mmol/L (54 mg/dL) confermato dal glucometro)
5. Numero di episodi ipoglicemici clinicamente significativi (livello 2) (inferiore a 3,0 mmol/L (54 mg/dL), confermato dal glucometro) o episodi ipoglicemici gravi (livello 3)
6. Tempo trascorso al di sotto di 3,0 mmol/L (54 mg/dL) utilizzando il sistema di monitoraggio continuo del glucosio (CGM), Dexcom G6
7. Tempo trascorso al di sopra di 10 mmol/L (180 mg/dL) utilizzando il sistema di monitoraggio continuo del glucosio (CGM), Dexcom G6
8. Dose settimanale media di insulina
9. Variazione del peso corporeo

E.5.2.1

Timepoint(s) of evaluation of this end point

1. From baseline week 0 (V2) to week 26 (V28)
2. From week 22 (V24) to week 26 (V28)
3.-5. From baseline week 0 (V2) to week 31 (V30)
6.-7. From week 22 (V24) to week 26 (V28)
8. From week 24 (V26) to week 26 (V28)
9. From baseline week 0 (V2) to week 26 (V28)

1. Dalla settimana 0 (V2) (valore basale) alla settimana 26 (V28)
2. Dalla settimana 22 8V24) alla settimana 26 (V28)
3-5. Dalla settimana 0 (V2) (valore basale) alla settimana 31 (V30)
6-7. Dalla settimana 22 (V24) alla settimana 26 (V28)
8. Dalla settimana 24 (V26) alla settimana 26 (V28)
9. Dalla settimana 0 (V2) (valore basale) alla settimana 26 (V28)

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Trattamento adattato per raggiungere il target

Treat-to-target design

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

India

Japan

Mexico

Russian Federation

United States

Finland

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

LVLS, Last Visit Last Subject, ultima visita dell'ultimo paziente

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

348

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

232

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

210

F.4.2.2

In the whole clinical trial

580

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

Nessuno

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2021-03-01

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-01-21

P. End of Trial
P.	End of Trial Status	Ongoing

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IMP with orphan designation in the indication
Orphan Designation Number:
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